Automatic-sealing balloon-filling catheter system

ABSTRACT

Valve assemblies for use with expandable devices that are positioned within remote cavities and more particularly relates to the catheters/conduits used to inflate these devices with fluid.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/286,321, filed Feb. 26, 2019, which is a non-provisional of U.S.Provisional No. 62/635,272, filed Feb. 26, 2018, the entirety of each ofwhich is incorporated by reference. This application is also related toPCT Application PCT/US2019/019630, filed on Feb. 26, 2019, the entiretyof which is incorporated by reference.

BACKGROUND OF THE INVENTION

The present invention generally relates to the field of balloon devicesthat occupy spaces within remote cavities and more particularly relatesto the catheters/conduits used to inflate these devices with fluid.

One example of balloon devices that occupy space in a remote cavity is aintragastric balloon for weight loss. According to 2010 World HealthOrganization data, 198 million Americans over the age of 15 are abovetarget weight. Of these individuals, 89 million are consideredoverweight (25<Body Mass Index<30) and 109 million are considered obese(Body Mass Index >30). Worldwide, more than 1.4 billion adults age 20and over are overweight, and 500 million are obese. Obesity placespatients at increased risk of numerous, potentially disabling conditionsincluding type 2 diabetes, heart disease, stroke, gallbladder disease,and musculoskeletal disorders. Compared with healthy weight adults,obese adults are more than three times as likely to have been diagnosedwith diabetes or high blood pressure. In the United States it isestimated that one in five cancer-related deaths may be attributable toobesity in female non-smokers and one in seven among male non-smokers(>=50 years of age). On average, men and women who were obese at age 40live 5.8 and 7.1 fewer years, respectively, than their healthy weightpeers.

For the vast majority of the overweight and obese population for whomsurgical obesity procedures are not appropriate, few efficacious andaffordable interventions are currently available. Diet and exerciseremain the front line approaches to obesity, however this approach hasat best slowed the growth of the epidemic. To date, drug therapies havedose limiting side effects or have lacked meaningful long term efficacy.

One less-invasive intervention that has begun to gain popularity is anintragastric balloon. Intragastric balloons in their uninflated statecan be placed endoscopically or positioned using other methods and, oncein place, are typically filled with a filling fluid through a thincatheter or conduit extending up the esophagus from the device in thestomach to an external fluid supply. This catheter is then removed fromthe device and extracted from the body through the esophagus. Uponremoval of the catheter, the catheter fill system must seal the fluidcommunication between the interior of the device and the gastricenvironment to maintain the balloon in its filled state for theproscribed time.

Several approaches to sealing the catheter system have been developed.For example, in US20130012980 Brister describes the use of a septum, orrubber-like plug, through which a filling needle is disposed. Uponremoval of the needle the rubber-like material elastically closes thepuncture. While such a system is well-accepted for inflating athleticequipment such as footballs, it does require the hard, rubber-likeseptum to remain in the intragastric balloon for the life of theballoon.

Another approach for use in breast implants has been disclosed by Beckerin US2010/0110311 in which a filling tube comprising a soft, flexiblehollow tube portion and a barbed, solid distal portion is pre-installedthrough a piece of “semi-rigid tube” that penetrates the balloon wall.The filling tube has an outer dimension that is slightly larger than theinner dimension of the semirigid tube and is stretchable longitudinallyto reduce the outer diameter to facilitate passage through thepassageway in the semirigid tube. Supposedly, the outer diameter of thesolid portion of the filling tube can be reduced by said longitudinalstretching to allow the solid portion to be pulled into the semi-rigidtube. The solid portion then sealingly engages the semirigid tube uponrelaxation thereof. The significant force that must be applied to thefilling tube to pull the solid portion into the semirigid tubeapparently requires that the semirigid tube is attached to the balloonwall by a reinforcing disk of material. However, this constructionprevents the balloon described by Becker from being compacted into aningestible capsule when uninflated. The inventor further notes thatexpansion of the solid portion upon relaxation is not adequate to ensurethe solid portion remains in the semirigid portion and that “A keyelement in the . . . invention resides in means such as a plurality ofreverse barbs for preventing a plug valve from being dislodged . . . ”

Commonly assigned publication US20130218190, discloses a self-sealingtunnel valve comprising two layers of thin film material through which aflexible fill catheter is disposed. The two layers tend to closetogether upon catheter withdrawal. This tunnel valve is extremely softand flexible, making it suitable for compaction into an ingestiblecapsule and for long term residence in the stomach.

It would be desirable to have a self-sealing valve that is small and/orsoft enough to be compacted into an ingestible capsule while alsoproviding a distinct sealed condition.

SUMMARY OF THE INVENTION

The present invention relates to devices and valve assemblies forremotely sealing an inflatable structure. For example, such devices canbe used to occupying a space within a patient's body. In particular, theinvention relates to catheter or conduit systems and methods for fillingthe devices and removing the catheter from the device and the patient'sbody without leakage of the filling fluid. In greater particularity, thepresent invention relates to catheter systems that automatically form apermanent seal for use in these space occupying devices.

In one variation, the present devices include valve assemblies. Suchvalve assemblies can be used with a balloon device (or any expandabledevice) having a fluid port. In one example the valve assembly includesa jacket member having an elongated shape, an outer surface and aninterior channel, the interior channel comprising an engagement member;a wall anchor positioned within the balloon device and adjacent to thefluid port , the wall anchor having an interior passage that receivesthe jacket member, where a portion of the balloon device adjacent to thefluid port extends into the interior passage of the wall anchor and issecured between the outer surface of the jacket member and the interiorchannel of the wall anchor; a conduit (or catheter/tube) extendingthrough the interior channel of the jacket member, the conduit having afill end and a balloon end, wherein the conduit and the interior channelare configured to have a sliding resistance therebetween; the conduithaving an interference region at the balloon end positioned within theballoon device, the interference region having a locking profile thatallows the interference region to become fixedly engaged within theinterior channel when moved therein; a weakened section located betweenthe fill end of the conduit and the interference region, wherein theweakened section has a reduced tensile strength less than a tensilestrength of the conduit while permitting sliding of the conduit relativeto the interior channel upon the application of a pulling force on theconduit without causing separation at the weakened section, wherein thereduced tensile strength requires a tearing force to cause separation ofthe conduit at the weakened section; and a fill opening located on theconduit between the fill end and the interference region, the fillopening positioned within the balloon device such that fluid enteringthe fill end exits at the fill opening into the balloon, where theballoon end is occluded to prevent fluid from flowing therethrough, suchthat application of the pulling force that overcomes the slidingresistance causes movement the fill opening and the interference regioninto the jacket member to seal the balloon device.

Variation of the device can include a jacket member comprises anelongated cylindrical shape.

In another variation, the balloon end of the conduit includes acylindrical plug having an external shaft diameter equal to or greaterthan an interior diameter of the conduit. The cylindrical plug caninclude a plug head sized to prevent movement through the interiorchannel of the conduit. In another variation, the cylindrical plugcomprises at least one tooth comprising a tapered shape that increases aforce required to remove the plug from the conduit.

A variation of the device can include a conduit that includes aspherical plug in the balloon end of the conduit, where an externaldiameter of the spherical plug is equal to or greater than an interiordiameter of the conduit. The inter interference region can be adjacentto the balloon end.

Variations of the conduit can include one or more weakened sectionslocated between the fill end and the interference region.

In another variation of the device, the interior channel of the jacketmember includes at least one engaging element that reduces an interiordiameter of the interior channel, wherein the interference region lockswith the at least one engaging element to seal the interior channel ofthe jacket member.

Variations of the wall anchor can comprises a flared end adjacent to theballoon device.

The fill openings in the conduit can comprise a plurality of fillopenings.

In additional variations, the portion of the balloon device canextending into the interior passage of the wall anchor extends to atleast a length of the jacket member.

In variations of the device, a proximal face of the wall anchor isadjacent to but unconnected with a wall of the balloon device.

In yet another variation, a friction fit between the conduit and theinterior passage of the jacket member creates a resistance between theconduit and interior passage of the jacket member that permits movementof the balloon device upon pulling the conduit.

The present invention also includes balloon device comprising one ormore variations of the valve structure described herein.

The present disclosure also includes methods for sealing and releasing afluid-filled balloon tethered to a conduit within a remote cavity andaccessible through a passage. For example, the method can includeretaining an end of the conduit outside of the passage, where theconduit is coupled to the fluid-filled balloon through a closureassembly, and where the conduit comprises a weakened section; applying afirst extractive force to the conduit to overcome a frictionalresistance between the conduit and the closure assembly causing theconduit to slide within the closure assembly until an interferenceregion of the conduit engages the closure assembly, wherein the firstextractive force is insufficient to separate the conduit at the weakenedsection; applying a second sealing force to overcome a sealingresistance between the interference region and the closure assembly toseat the interference region within the closure assembly to form a sealtherebetween, where the second sealing force is greater than thefrictional resistance but is insufficient to separate the conduit at theweakened section; applying a third detachment force, the detachmentforce being greater than the second sealing force, wherein applicationof the detachment force causes separation of the conduit at the weakenedsection; and withdrawing the conduit from the passage.

One variation of the method can further comprise applying a positioningforce to the conduit, where the positioning force is less than the firstextractive force and causes movement of the fluid-filled balloon andconduit within the remote cavity.

The methods described herein can include positioning the fluid-filledballoon against an anatomic structure in or surrounding the remotecavity, wherein the anatomic structure applies a physical resistanceagainst movement of the fluid-filled balloon.

The resistance of the balloon member described herein can include aresistance against the balloon member when engaging a surface of thebody cavity or a surface of the passage. Alternatively, or incombination, a fit between the conduit and the closure assembly cancreate a fluid seal at an interface of the conduit and the interior ofthe closure assembly. In another variation, a fit between the conduitand the closure assembly can creates a fluid seal at the closureassembly when the interference region is positioned within the interiorof the closure assembly.

Yet another variation of a method described in the present disclosureincludes a method for filling a space in a remote cavity within a bodyand accessible through a passage. Such a method can include retaining anend of a conduit outside of the body; advancing the conduit and aballoon member into the remote cavity through the passage, where theconduit is coupled to the balloon member through a closure assembly, andwhere the conduit comprises a weakened section positioned within theballoon member; delivering a fluid through the conduit into the balloonmember to increase a size of the balloon member; initially applying aproximal force on the conduit such that a resistance of the balloonmember causes the conduit to slide relative to an interior of theclosure assembly until an interference region on the conduit contactsthe interior of the closure assembly to provide a locking resistance,increasing the initial proximal force on the conduit to overcome thelocking resistance and lockingly seats the interference region withininterior of the closure assembly and seals the closure assembly and theballoon; further increasing the proximal force on the conduit causefailure of the conduit at the weakened section such that a section ofthe conduit proximal to the weakened section separates from the closureassembly and balloon member; and retracting the section of the conduitfrom the passage.

The present disclosure can also include catheter systems for use withfluid filled balloons for occupying a space within the patient's body.In one example such a medical device includes a liquid impermeablesurface material forming a device body having an interior reservoir, thedevice body having a deployment profile and being expandable to anactive profile upon receiving the liquid filler material within theinterior reservoir; a fluid catheter comprising an extended sectionextending from the device to the exterior of the patient's body and adevice section, the latter section passing through a fluid path, orcatheter jacket, to provide a fluid filling material to the interiorreservoir of the device body, where the catheter jacket is held in placein a wall of the device body by a balloon wall anchor, and where theextended section of the catheter is removable from the catheter jacket,such that upon removal of the extended portion of the catheter, thedevice section remains in the fluid path, which is thereby automaticallyclosed to prevent liquid transfer to or from the patient's body.

The valves described herein provide a secure seal upon removal of thecatheter from the device where the seal can optionally be permanent. Thevalves can include a design and materials that permit packaging in acompact configuration. Variations of the valves can be soft enough to beleft in a patient's stomach for extended period without irritation tothe stomach. Additional variations of the valve can reduce incidents ofdamage to the valve or associated device during manufacture or storage.Additional variations of the valve allow for balancing of materialproperties to allow for improved catheter removal by stretching andtearing at a designed tension.

The above and other features of the invention including various noveldetails of construction and combinations of parts, and other advantages,will now be more particularly described with reference to theaccompanying drawings and pointed out in the claims. It will beunderstood that the particular method and device embodying the inventionare shown by way of illustration and not as a limitation of theinvention. The principles and features of this invention may be employedin various and numerous embodiments without departing from the scope ofthe invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other objects, features and advantages of the methods,devices, and systems described herein will become apparent from thefollowing description in conjunction with the accompanying drawings, inwhich reference characters refer to the same parts throughout thedifferent views. The drawings are not necessarily to scale; emphasis hasinstead been placed upon illustrating the principles of the invention.Of the drawings:

FIGS. 1A is a schematic block diagram of a fluid fillable balloondevice.

FIG. 1B illustrates a fluid fillable balloon device being filled.

FIG. 2A is a cutaway view of a variation of an Automatic-SealingCatheter Assembly (“ASCA”) installed in a thin film wall of a balloondevice.

FIGS. 2B is close up of the ASCA of FIG. 2A

FIG. 3A is a cutaway view of another variation of an ASCA.

FIG. 3B is an exploded cutaway view of the variation of an ASCA of FIG.3A.

FIG. 4A illustrates a variation of the ASCA while a balloon is beingfilled.

FIG. 4B illustrates the ASCA of FIG. 4A in its sealed configurationafter a balloon is filled.

FIG. 5A-5G illustrate seven variations for a plug for an ASCA.

FIG. 6A-6C illustrate three variations of fill ports for an ASCA.

FIG. 7A-7C illustrates three variations of a wall a for an ASCA.

FIG. 7D illustrates the relationship between the interior diameter ofthe exterior engagement element of FIG. 7C and the frictional forceholding a catheter in place.

FIG. 7E is a cutaway view of another variation of a catheter jacket.

FIGS. 8A to 8C illustrates an example of a deployment process of adevice and valve assembly.

FIG. 9 is a cutaway illustration of a balloon wall anchor for an ASCA.

FIG. 10 illustrates an ASCA comprising a miniature check valve.

FIG. 11 illustrates a second variation of an ASCA comprising a miniaturecheck valve.

DETAILED DESCRIPTION OF THE INVENTION

The following illustrations are examples of the invention describedherein. It is contemplated that combinations of aspects of specificembodiments or combinations of the specific embodiments themselves arewithin the scope of this disclosure. The methods, devices, and systemsdescribed herein can be used to improve gastric balloon devices.However, the devices, methods, and systems of the present disclosure canalso be useful in other medical and non-medical applications thatrequire a fluid-filled device with a removable filling system.

FIG. 1A illustrates schematic block diagram of a fluid fillable balloondevice 100; in particular, it illustrates a gastric balloon deviceassembly 100. FIG. 1B is an illustration of device 100 in place in apatient's stomach. The device generally comprises two states ofinterest: a pre-deployment or uninflated configuration and a deployed,inflated or active configuration; the deployed configuration is shown.Generally, the device is inflated with a fluid. For example, the fluidcan be delivered through a tube 110 also referred to herein as acatheter or conduit, wherein the tube may pass through a lumen in thewall of the balloon device or is coupled to a fluid path 112 between theexterior and the interior of the balloon device. In alternativevariations, the fluid can be delivered using any type of device that candeliver fluid. In many balloon devices a wall 102 of the balloon 100 isfabricated from a thin film material such as, for example, polyurethane.In some variations the tube 110 comprises a balloon end or internalsection 110A that extends through fluid path 112 into the centralenclosed space or reservoir 104 of device 100. In other variationsinternal section 110A stops before entering the reservoir or is justadjacent to the reservoir 104. The conduit 110 is removed from thedevice once inflation is completed. When the conduit is removed, fluidpath 112 must be sealed to prevent the fluid from leaking out throughfluid path 112 from reservoir 104. As shown schematically in FIG. 1A,sealing is accomplished by fill valve, which may comprise an internalsection 113B, an external section 113A, or a combination of both. Insome variations, elements of the fill valve 113 may have componentsinstalled inside conduit 110 as well as in fluid path 112.

Some variations of a gastric balloon device assembly 100 furthercomprise a fluid release valve 126. In some variations release valve 126is independent from fill valve 113. However, in some variations, releasevalve 126 may be combined, at least in part, with fill valve 113. Insome variations, release valve 126 reverses the operation of the sealingmechanism of fill valve 113.

In some variations, the fluid path itself serves as the fill valve,wherein the fluid path itself closes down to prevent fluid from escapingfrom reservoir 104. In other variations the fluid path is sealed by anautomatic-sealing catheter assembly 10, which is a separate valvemechanism installed in the fluid path or in a portion of the conduitleft behind in the fluid path when the main length of the conduit iswithdrawn from the patient's body. FIG. 2A illustrates a partialcut-away view of one variation of the device 100 in the region of fillvalve as it might appear within a patient's stomach, ready to beinflated. In this variation, the fill valve is an automatic-sealingcatheter assembly (ASCA) 10. The variation shown in FIG. 2A includes acatheter 110 that extends from interior section 110A to outside ofdevice 100, typically extending far enough to reach the exterior of thepatient, where the balloon thin film wall 102 defines the divisionbetween the interior and the exterior of the device.

FIG. 2B is a close up cutaway view of the ASCA 10 of FIG. 2A. Theassembly comprises the internal section 110A of catheter 110, the end ofwhich has been sealed shut with a plug 120, in this variation by atoothed plug 120, during assembly. The plug has one or morecircumferential, or partially circumferential, teeth or projections 115which create rings or bulges 116 that cause an increased diameter on theexterior of internal section 110A. The circumferential projections 115also work to lock plug 120 into section 110A substantially permanently,although glue, welding, or other bonding approaches could be used tolock a plug into section 110A. The catheter further comprises one ormore side-wall openings or fill ports 130, where the variation with onefill port is show in the figures, wherein the fill ports are disposed tobe clear from plug 120 to allow filling fluid coming through thecatheter to freely enter the balloon. In the illustrated variation, acatheter jacket 210 has been inserted through a section of balloon wall102 from the exterior of the balloon and is held in place by pinchingballoon wall 102 between the exterior of catheter jacket 210 and theinterior of a balloon wall anchor 310. In the illustrated variation, thecatheter further comprises a weakened section 150 designed to definewhere and with what tension the catheter will tear apart. In onevariation, section 150 is a slit extending part way across conduit 110.

The cross-sectional view in FIG. 3A illustrates another variation ofASCA 10. In this variation, the toothed plug has been replaced with aspherical plug 125, for example a ball bearing. Also, in this variationa retaining ring 410 has been added to reinforce wall anchor 310. Anexploded, cross-sectional view of the ASCA 10 of FIG. 3A is illustratedin FIG. 3B for clarity.

FIG. 4A illustrates an example of the automatic-sealing behavior of thecatheter assembly of FIG. 3. FIG. 4A illustrates ASCA 10 as fluid entersa balloon device 100. As has been discussed above, balloon 100 isinflated by injecting a fluid 1000 at a catheter fill end 110B. Thefluid travels the length of the catheter and exits the catheter througha catheter fill port 130 disposed proximate or, in close proximity to, acatheter balloon end 110A, where the catheter balloon end 110A isintended to be inserted far enough into the balloon such that the fillport 130 is completely unobstructed by the other components of thevariation of ASCA 10.

Of course, if this condition is not met the balloon will still inflateif at least a portion of the port is unobstructed, albeit at a slowerrate. After a proscribed volume of fluid has been injected into theballoon, or, alternatively, a proscribed back pressure of the fluid hasbeen reached, catheter 110 is withdrawn from the patient. However, tomaintain inflation of the balloon 100 fluid path 112, which normallywould allow two-way fluid flow, must prevent exit of the fluid toprevent deflation of the balloon.

FIG. 4B illustrates a partially withdrawn catheter 110 in a sealingposition. As shown, catheter 110 has been pulled into catheter jacket210 until it moves plug 125 between the engagement elements 212 builtinto the inner surface of jacket 210. In the illustrated variation,catheter 110 is secured in the sealing position when catheter wallbulges 116 formed by plug 125 abut engagement elements 212, which, inthis variation, are ridges in the inside of catheter jacket 210. In thisconfiguration the fill port 130 is no longer in fluid communication withthe interior of the balloon and the exterior of the catheter iscompressed between the internal ridges and the plug, in this caseoperating like an o-ring, effectively sealing the catheter assembly.Once the catheter balloon end 110A has been secured in the catheterjacket, any further increase in axial tension on the catheter areapplied to tear the catheter to allow the majority of catheter 110 to beextracted from the patient while leaving catheter balloon end 110A incatheter jacket 210, as indicated in FIG. 4B. By design, tear-away slit150 (shown in FIG. 3B) creates a unique location at which the catheterwill tear; additionally, by design, the force at which the cathetertears can be adjusted to any reasonable value by varying the depth orshape of slit 150.

Each of the elements of the ASCA can take multiple forms that effect thesame results. For example, as shown in FIG. 5A through 5 g, plug 120 canhave just one (FIG. 5B), instead of two (FIG. 5C), circumferential teeth115, or a plug shaft 122 can be smooth sided (FIG. 5A). In othervariations plug 120 can be a small ball bearing 125 (FIG. 5D) or theplug can be a measured amount of hardening material, for example, glue127 injected into the end of the catheter 110 (FIG. 5F) or the distinctplug can be replaced by simply sealing the balloon end of catheter 110(FIG. 5E). This seal can be effected by pinching the open end 117 of thecatheter and thermally sealing it closed, by gluing it closed, or by anyother convenient means for eliminating a distinct plug component. In yetanother variation, shown in FIG. 5G, plug 120 includes a shaft 122 thatis generally smooth sided except for a bulbous protrusion 118 at itstip.

In many variations plug 120 comprises plug shaft 122 and a plug head 121wherein plug shaft 122 has a main diameter substantially equal to theinterior diameter of catheter 110 while plug head 121 has a diameterlarger than the internal diameter, IDc, of catheter 110 to facilitateinsertion and/or removal of plug 120 from the catheter and, in somevariations, plug head 121 has a diameter larger than the externaldiameter of catheter 110 to improve retention of the catheter balloonend 110A inside balloon jacket 210 as the major portion of the catheteris removed from the patient's body. In some variations the plug shaft122 comprises one or more teeth 115 wherein the teeth are disposed topermit plug 120 to be inserted into catheter balloon end 110A withrelatively little extra resistance but are shaped to dig into therelatively soft catheter material when force is exerted in the directionto extract plug 120 from catheter 110. Furthermore, for reasonsdiscussed below, the diameter of the teeth is, by design, selected toform localized expanded bands, rings, or bulges 116 around the exteriorof catheter 110. The region having these expanded bands is theinterference region, so-called because the region has a mechanicalinterference with the engagement elements in jacket 210.

Plug 120 may be fabricated from any substantially incompressible,bio-compatible material. In one variation the plug is fabricated fromstainless steel. In one variation in which a ball bearing is used asplug 120 the diameter of the ball bearing is designed to providesubstantially the same functions as a toothed plug, that is, thediameter of the ball bearing is slightly larger than IDc, thus bothplugging catheter 110 and forming one expanded band around the exteriorof catheter 110.

Similarly, as shown in FIG. 6A through 6C, fill port 130 illustrated inFIG. 2 can be functionally replaced by other designs. FIG. 6Aillustrates a single fill port 130 in catheter 110, whose size isdetermined by the net port open area designed to fill the balloonwithout creating excessive backpres sure or slow fill rates. In FIG. 6Bthe single fill port replaced by two or more, possibly smaller, ports130A. These two ports are shown as diametrically opposed but they may belocated anywhere around catheter 110. Further, port 130 can even bereplaced by micro-drilled perforations 131, as shown in FIG. 6C, in aband around the catheter 110, this latter approach maintains rotationalsymmetry of the structure of the catheter 110 while still providing thedesired net open area in the catheter. Laser micro machining by a vendorsuch as Resonetics, 44 Simon St. Nashua, N.H. can be advantageously usedto create these small, closely packed openings 131 in the cathetermaterial.

FIG. 7 illustrates in cutaway variations of catheter jacket 210. In itsmost basic configuration, not illustrated, jacket 210 comprises a rigidcylindrical tube. In some variations jacket 210 has an internal diametersmaller than the catheter's outer diameter by a small amount, say 0.010inches. In many variations, jacket 210 further comprises one or moreraised engagement elements 212, wherein the elements 212 may be distinctbumps, knobs, or teeth, as shown in FIG. 7B, or they may be continuousridges or rings as shown in FIG. 7A. In all cases engagement elements212 reduce the internal clearance of the jacket to be less thancatheter's 110 outer diameter to provide frictional engagement, ormechanical interference, between the jacket 210 and the interferenceregion of catheter 110. In some cases, the engagement element can gentlydig into the exterior of catheter 110. This diametrical difference ispreferably between 0.001 inches and 0.050 inches; more preferablybetween 0.005 inches and 0.020 inches; and most preferably between 0.006and 0.010 inches

In some variations one or more of these raised elements may beasymmetric relative to the axis of symmetry of jacket 210, that is, theinterior edge 214 and the exterior edge 216 may have different slopeangles. In one variation the interior edge 214 is sloped to facilitatepulling catheter balloon end 110A from the exterior side into jacket 210to seal the ASCA while exterior edge 216 is more perpendicular to theinterior wall of jacket 210 to inhibit, but not preventing, catheterballoon end 110A from moving inwardly after the rest of catheter 110 hasbeen torn away.

In other variations, as suggested in FIG. 4B, other engagement elements212 may be configured to help form a fluid tight seal when plug 120 ispulled into jacket 210. In some variations, as shown in FIG. 7C, theremay be two or more sets of engagement elements. The outermost (that is,closest to the exterior of balloon 100) engagement elements 212A have asmall enough inner diameter to prevent plug 120 (shown as ball bearing125 in FIG. 4B) from being pulled out jacket 210 when catheter 110 isextracted, whilst innermost elements 212B prevent plug 120 frommigrating back into balloon reservoir 104 once the plug is in thesealing position. Innermost elements 212B also help to form afluid-tight seal by squeezing plug 125 against outermost elements 212Awhen there is a compressible section of catheter therebetween.

That is, some of engagement elements 212 are configured to compress anddig into catheter 110 to hold catheter balloon end 110A inside gastricdevice 100 under small, incidental extractive loads but not retaincatheter balloon end 110A inside the gastric device under the larger,intentional extraction load used to detach the catheter from the device.As illustrated in the graph in FIG. 7D, the frictional force holding aprototypical polymeric catheter back from extraction generated byoutermost or exterior engagement elements 212A of a compatibly designedjacket may be determined at the time of design to span a wide range.

In general, the elements that comprise the ASCA are intended to controlthe frictional/retention force that holds the catheter 110 in the ASCAduring the deployment process. As illustrated in FIGS. 8A-8C, forpurposes of illustration, there are three stages in the deploymentprocess, where the maximum retaining force that holds the catheterwithin the device varies in each stage. As shown in FIG. 8A, for agastric balloon variation, the first stage that occurs after positioningthe device in the stomach 20 is a filling stage, during which themedical caregiver begins to infuse fluid into the empty device 100 (orpartially empty device). During this stage, device 100 can be consideredas a weighted mass at the end of the catheter 110. As device 100 fillswith fluid, especially when the fluid is a liquid, the weight of theballoon 100 increases from the weight of just the un-inflated thin filmballoon. In one variation, the filled balloon weight (“WB”) isapproximately 500 grams. In some variations, the filled device is atleast partly supported by surrounding tissue or, in the case of agastric balloon, by the contents of the stomach, which reduces theeffective weight applied by the balloon on the catheter. To keep device100 from pulling away from, or sliding off, catheter 110 before thefilling process is completed, the force that retains the catheter withinthe valve (the sliding resistance threshold or retention force “FR”)must be greater than the effective weight (“WE”) or else the weight ofthe balloon could cause pre-mature detachment of the catheter or sealingof the valve.

As shown in FIG. 8B, a second stage of the deployment process seals theASCA. Closing this valve requires pulling balloon end 110A of catheter110 into fluid path 112 such that the fill port 130 is withdrawn fromthe reservoir of the balloon 100. As illustrated, this stage of theprocess comprises pulling the catheter 110 in a proximal direction(e.g., towards the esophagus 22) until filled device 100 encountersresistance to motion against the esophageal sphincter 24. Once device100 abuts sphincter 24, continued application of the proximal forceincreases the tension in catheter 100 until the tension is greater than,and overcomes, the FR, allowing the catheter internal end 110A to slideinto fluid path 112 with a sliding resistance somewhat below the slidingresistance threshold. This movement closes the valve. The force requiredto overcome FR is the called a “closing force” or “FC”. In general, theFC is a “threshold” force, meaning that once FC overcomes FR, the forcerequired to maintain movement of the catheter will be less than FC,since sliding friction is less than static friction/resistance.

As catheter 110 is pulled into fluid path 112, plug 120 reachesengagement elements 212A (not shown in FIG. 8A) and cannot move anyfurther.

As illustrated in FIG. 8C, the majority of catheter 110 is disconnectedfrom device 100 and removed from the patient's body. Only internalsection 110A, which is part of ASCA 10, remains in device 100 afterdevice deployment. With the device lodged against esophageal sphincter24 the disconnection of catheter 110 is effected by pulling on thecatheter with increasing force until the tension in catheter 110 exceedsa tear force, FT, which causes the catheter to separate at weakenedsection 150, in this variation a slit, where the depth of slit 150 hasbeen designed to keep the tear force FT below a force, FE, that woulddamage the esophageal sphincter. Note that in some variations tear slit150 is replaced by other means of weakening the catheter at the desiredtear location to achieve a safe disconnection of catheter 110.

The primary means of controlling the various forces are the materialproperties of the catheter material and the internal diameters andprofiles of the internal features of catheter jacket 210. For example,FIG. 7D illustrates the relationship between the internal diameter of anengagement element (“Barb ID”) and the frictional force/resistance feltby a catheter, as measured for an exemplary embodiment of element 212Aand catheter 110.

During the design of ASCA 10, several relationships must be considered.First, to prevent the catheter from moving during the balloon fill stageof deployment,

-   -   FR>WE.        Second, to initiate the closing of the ASCA by starting the        catheter moving into the catheter jacket,    -   FC>FR.        Third, to prevent injury to the patient,    -   FT<FE, and    -   FR<FE.        Finally, to prevent the catheter from tearing before the valve        is closed    -   FT>FC.

Based on experimental experience which determined both the WE and theFE, in one variation FR is preferably, 0.25 lbf<FR<1.6 lbf and morepreferably 0.6 lbf<FR<1.1 lbf. where 1.6 lbf was determined to be safelybelow FE for human patients. Further, 1.25 lbf<FT<1.6 lbf. Note that FCis not a free design parameter because it is always equal to the FR ofthe specific as-built valve. (that is, the valve starts closing as soonas FC exceeds the threshold of FR).

The construction of the device shown above, with the various range offorces is especially useful in those situations such as a gastric devicewhere deployment, filling, sealing, and detachment occurs remotelywithin the stomach. In such a case, it is desirable to close the valveand detach the conduit without supporting or holding the valve bysupplementary means. Since the device is within the stomach, providingsupport to the valve or cutting the catheter would require a tooladvanced through the esophagus causing the procedure to increase incomplexity.

Another variation of a catheter jacket is illustrated in cutaway view inFIG. 7E. In this variation the distinct engagement elements of previousvariations are replaced by closely spaced, tapered internal diameterridges 212C. These ridges apply an increasingly tight grip on thecatheter as catheter balloon end 110A is pulled further outwardly,whereas engagement elements 212A tend to grip the catheter with aconstant force, independent of how far the catheter has been pulled.

In some variations, as illustrated previously, jacket 210 is affixed toa portion of the balloon wall material, either a free-standing patch ora relatively smooth portion of the actual balloon wall at, for example,a polar region of an oblate spheroid balloon. In other variations,jacket 210 can be fabricated from a short piece of polymer tubing suchas polyurethane, which is compatible with welding or gluing into anequatorial seam between two halves of a polymer, for examplepolyurethane, balloon.

In some variations jacket 210 may be held in place by a balloon wallanchor 310. In variations utilizing a balloon wall anchor, the thin filmof material (either in the form of a section of the balloon wall 102 ora separate patch of material) is pinched between catheter jacket 210 andballoon wall anchor 310, locking catheter jacket 210 in place in theballoon wall. As shown in FIG. 9, anchor 310 may comprise one or moreinternal rings or teeth 320 to lock jacket 210 in place. In thevariation shown in FIG. 9, anchor 310 comprises an inward-facing lip 315which prevents catheter jacket 210 from entering the interior of theballoon device. Further, anchor 310 comprises inward facing nubs 320that are shaped to allow jacket 210 to slide over them when beinginserted from the exterior side of the balloon but which lock it inplace once the end of the jacket passes the edge of the nubs.Additionally, some variations of anchor 310 comprise a flared exteriorfacing end 330, as shown in FIGS. 2B and 3A. Flaring this end of wallanchor 310 provides a smooth and expanded contact surface between theanchor and the thin-film wall material, reducing the probability oftearing the wall material. In some variations anchor 310 is fabricatedfrom polymer material to reduce the probability of damage to the thinfilm wall material 102, which is sandwiched between jacket 210 andanchor 310.

As shown in FIG. 3B, in some variations of the ASCA a retaining ring 410is installed over balloon wall anchor 310. In some variations retainingring 410 comprises a thin walled, stiff cylindrical tube with a closeinner diameter-to-wall anchor outer diameter tolerance designed tocapture the thin film wall material in a press fit. In variations with asoft anchor, the retaining ring provides the creep resistance andstiffness normally found in a metal wall anchor. An advantage of thisvariation is that a metal catheter jacket, for example stainless steel,can be pressed through the region of thin-film wall material and up intothe soft/compliant wall anchor without the force from the press fitcausing the film to shear. The soft wall anchor acts as a cushion forthe film between a stiff, metal catheter jacket and a stiff, metalretaining ring so that a strong press fit can be achieved.

The ASCA can be fabricated on a separate patch of balloon-compatiblematerial or assembled in situ in a wall of the balloon device. A processfor fabricating the automatic-sealing catheter assembly typicallycomprises the following steps:

1) Identifying a region of thin-film material balloon wall suitable forinstallation. Such region is typically substantially flat andapproximately 45 millimeters in diameter. In some applications in whichthe balloon is a highly oblate spheroid this region may be at one of thepoles of the spheroid. In other variations the installation region maybe on a separate patch of material known to be compatible with the thinfilm material of the balloon. In typical variations the patch ofmaterial is between 0.0025 and 0.005 inches thick. The patch of materialwill later be installed over a hole in the balloon device in a regionthat is typically substantially flat, such as at one of the poles of ahighly oblate spheroidal balloon. In certain variations the installationregion may be on a seam in the balloon wall.

2) Placing the thin film material in a fixture comprising two rigidplates, each of which have a central through hole with a diametercommensurate with the catheter jacket. The material region is sandwichedbetween the two plates and typically centered on the through hole.

3) Pushing the jacket up through the hole from a first side of thefixture, stretching the film over the jacket in the process. The firstside of the fixture corresponds to the exterior of the balloon anddefines an exterior side of the finished ASCA.

4) Pressing the wall anchor over the jacket and film from a second sideof the fixture, captivating the film between the jacket and the wallanchor. The second side of the fixture corresponds to the interior ofthe balloon.

5) Removing the jacket-film-anchor subassembly from the rigid plateassembly.

6) Optionally pressing the retaining ring over the subassembly from whathad been the second side of the fixture. The retaining ring should bebottomed out against the end of the wall anchor.

7) Separately, preparing the catheter balloon end. Typically, thispreparation comprises:

-   -   a. Creating one or more fill ports.    -   b. Cutting one or more tear-away slits.

8) Inserting the prepared catheter balloon end into the subassembly fromthe exterior side of the ASCA, allowing the balloon end to project pastthe end of the rest of the subassembly by a convenient working distancebut at least far enough to expose the fill port(s).

9) Inserting the plug into the open lumen of the catheter balloon endor, alternatively, sealing the open lumen of the catheter balloon end.

10) Withdrawing the catheter from the exterior side of the ASCA toeliminate excess catheter length on the interior side of the ASCA,leaving the fill port(s) exposed.

In some variations of the ASCA the functions of the plug and fillport(s) can be combined by using a micro-check valve 123. For example,both axial and side exit micro-check valves are available from The LeeCompany, 2 Pettipaug Road, PO Box 424, Westbrook, Cobb. 06498. See, forexample, Lee part number CCPI25100xxS, where xx is the crackingpressure. In one of these variations the check valve may be installed incatheter balloon end 110A as a direct replacement for plug 120, asillustrated in FIG. 10, in which case the ASCA is similar to thevariations described above, except there is no need for the catheter tocomprise one or more fill ports. Instead, the fluid flows through thecatheter and the (forward) pressure opens the check valve in the end ofthe catheter, allowing the fluid to enter reservoir. When the forwardpressure stops, the check valve seals the end of the catheter. When theballoon is adequately filled the catheter is removed as previouslydescribed but the catheter balloon end is retained in the catheterjacket by the “plug” formed by the micro-check valve. As before,extractive forces above the design level cause the catheter to tear awayat tear away slit 150.

An alternative variation, shown in FIG. 11, incorporates a micro-checkvalve 123 directly into the end of wall anchor 310 or retaining ring410. In this latter variation the micro-check valve is part of theballoon device and the catheter is inserted into and held in catheterjacket 210 independently from the presence of a plug. By the design ofcatheter jacket 210, small withdrawal forces are inadequate to pullcatheter 110 out of catheter jacket 210 but more significant withdrawalforces can pull the catheter from the catheter jacket. Such withdrawalcan be accomplished with or without a tear slit.

1. A valve assembly for use with a balloon device having a fluid port,the valve assembly comprising: a jacket member having an outer surfaceand an interior channel; a wall anchor configured to be positionedadjacent to the fluid port, the wall anchor having an interior passagethat receives the jacket member to secure a portion of the balloondevice therebetween; a conduit extending through the interior channel ofthe jacket member, the conduit having a fill end and a balloon end, witha fill opening located therebetween, wherein the balloon end is occludedsuch that fluid can pass between the fill end and the fill openingwherein a portion of the conduit and the interior channel are sized tocreate a sliding resistance therebetween; the conduit having aninterference region between the fill opening and the balloon end, suchthat when the conduit moves within the interior channel to position theinterference region into the interior channel the interference regionbecomes secured therein and seals the valve by moving the fill openingthrough or out of the interior channel; and a weakened section on theconduit and located towards the interference region, wherein a tensilestrength of the weakened section permits a pulling force on the conduitto overcome the sliding resistance and move the conduit within theinterior channel but causes failure of the conduit at the weakenedsection when the pulling force pulls the conduit subsequent to theinterference region being secured in the interior channel.
 2. The valveassembly of claim 1, where the jacket member comprises an elongatedcylindrical shape.
 3. The valve assembly of claim 1, where the balloonend of the conduit includes a cylindrical plug having an external shaftdiameter equal to or greater than an interior diameter of the conduit.4. The valve assembly of claim 3, where the cylindrical plug comprises aplug head sized to prevent movement through the interior channel of theconduit.
 5. The valve assembly of claim 3, wherein the cylindrical plugcomprises at least one tooth comprising a tapered shape that increases aforce required to remove the plug from the conduit.
 6. The valveassembly of claim 1, wherein the conduit includes a spherical plug inthe balloon end of the conduit, where an external diameter of thespherical plug is equal to or greater than an interior diameter of theconduit.
 7. The valve assembly of claim 1, wherein the interferenceregion is adjacent to the balloon end.
 8. The valve assembly of claim 1,wherein the weakened section is located between the fill end and theinterference region.
 9. The valve assembly of claim 1, where theinterior channel of the jacket member includes at least one engagingelement that reduces an interior diameter of the interior channel,wherein the interference region locks with the at least one engagingelement to seal the interior channel of the jacket member.
 10. The valveassembly of claim 1, wherein the wall anchor comprises a flared endadjacent to the balloon device.
 11. The valve assembly of claim 1, wherethe conduit includes a plurality of fill openings.
 12. The valveassembly of claim 1, wherein the portion of the balloon device extendinginto the interior passage of the wall anchor extends to at least alength of the jacket member.
 13. The valve assembly of claim 1, whereina proximal face of the wall anchor is adjacent to but unconnected with awall of the balloon device.
 14. The valve assembly of claim 1, wherein afriction fit between the conduit and the interior passage of the jacketmember creates a resistance between the conduit and interior passage ofthe jacket member that permits movement of the balloon device uponpulling the conduit.
 15. A balloon device comprising: a balloon layerdefining a reservoir, the reservoir having a fluid port; a jacket memberhaving an outer surface and an interior channel,; a wall anchorpositioned within the reservoir and adjacent to the fluid port, the wallanchor having an interior passage that receives the jacket member tosecure a portion of the balloon layer therebetween; a conduit extendingthrough the interior channel of the jacket member, the conduit having afill end and a balloon end, with a fill opening located therebetween,wherein the balloon end is occluded such that fluid can pass between thefill end and the fill opening wherein a portion of the conduit and theinterior channel are sized to create a sliding resistance therebetween;the conduit having an interference region between the fill opening andthe balloon end and located within the reservoir, such that when theconduit moves within the interior channel to position the interferenceregion into the interior channel the interference region becomes securedtherein and seals the valve by moving the fill opening through or out ofthe interior channel; and a weakened section on the conduit and locatedtowards the interference region, wherein a tensile strength of theweakened section permits a pulling force on the conduit to overcome thesliding resistance and move the conduit within the interior channel butcauses failure of the conduit at the weakened section when the pullingforce pulls the conduit subsequent to the interference region beingsecured in the interior channel.
 16. The balloon device of claim 15,where the jacket member comprises an elongated cylindrical shape. 17.The balloon device of claim 15, where the balloon end of the conduitincludes a cylindrical plug having an external shaft diameter equal toor greater than an interior diameter of the conduit.
 18. The balloondevice of claim 17, where the cylindrical plug comprises a plug headsized to prevent movement through the interior channel of the conduit.19. The balloon device of claim 17, wherein the cylindrical plugcomprises at least one tooth comprising a tapered shape that increases aforce required to remove the plug from the conduit.
 20. The balloondevice of claim 15, wherein the conduit includes a spherical plug in theballoon end of the conduit, where an external diameter of the sphericalplug is equal to or greater than an interior diameter of the conduit.21. The balloon device of claim 15, wherein the interference region isadjacent to the balloon end.
 22. The balloon device of claim 15, whereinthe weakened section is located between the fill end and theinterference region.
 23. The balloon device of claim 15, where theinterior channel of the jacket member includes at least one engagingelement that reduces an interior diameter of the interior channel,wherein the interference region locks with the at least one engagingelement to seal the interior channel of the jacket member.
 24. Theballoon device of claim 15, wherein the wall anchor comprises a flaredend adjacent to the balloon device.
 25. The balloon device of claim 15,where the conduit includes a plurality of fill openings.
 26. The balloondevice of claim 15, wherein the portion of the balloon device extendinginto the interior passage of the wall anchor extends to at least alength of the jacket member.
 27. The balloon device of claim 15, whereina proximal face of the wall anchor is adjacent to but unconnected with awall of the balloon device.
 28. The balloon device of claim 15, whereina friction fit between the conduit and the interior passage of thejacket member creates a resistance between the conduit and interiorpassage of the jacket member that permits movement of the balloon deviceupon pulling the conduit.